Midazolam

Product NDC: 70518-4328
11-digit product format: 705184328
Labeler code: 70518
Product ID: 70518-4328_402f646b-1f17-d819-e063-6394a90ab1d8
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: midazolam hydrochloride
Dosage form: INJECTION, SOLUTION
Route: INTRAMUSCULAR; INTRAVENOUS
Labeler: REMEDYREPACK INC.
Application: ANDA090315
Marketing category: ANDA
Marketing start: 2025-04-14
Substance: MIDAZOLAM HYDROCHLORIDE
Active strength: 2 mg/2mL
Pharmacologic classes: Benzodiazepine [EPC], Benzodiazepines [CS]
DEA schedule: CIV
NDC exclude flag: No
Listing certified through: 2026-12-31
Current FDA listing: Yes

Source provenance: Browse the complete Orange Book source catalog · source snapshot 42.

Orange Book products#

Current product rows page 1 of 1 · 2 matching rows.

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	TE codes	RLD / RS	Approval date
A090315-001	MIDAZOLAM HYDROCHLORIDE PRESERVATIVE FREE	MIDAZOLAM HYDROCHLORIDE	EQ 1MG BASE/ML	INJECTABLE / INJECTION	AP		2010-11-29
A090315-002	MIDAZOLAM HYDROCHLORIDE PRESERVATIVE FREE	MIDAZOLAM HYDROCHLORIDE	EQ 5MG BASE/ML	INJECTABLE / INJECTION	AP		2010-11-29

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 2 matching rows.

Application-product, TE code table
Application-product	TE code
A090315-001	AP
A090315-002	AP

Observed Orange Book product history#

Observed FDA ZIP history: Each table is queried independently by exact application/product key from successfully parsed Orange Book snapshots. Capture times identify archived source observations; absence or a change between snapshots is not inferred. FDA publication files that were not recoverable as structured ZIP data are not represented as states.

Product history page 1 of 3 · 84 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	Product TE source text	Approval date	Source SHA-256
2026-08-18 06:07:40	2026-07	A090315-001	MIDAZOLAM HYDROCHLORIDE PRESERVATIVE FREE	EQ 1MG BASE/ML	INJECTABLE / INJECTION	AP	2010-11-29	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A090315-002	MIDAZOLAM HYDROCHLORIDE PRESERVATIVE FREE	EQ 5MG BASE/ML	INJECTABLE / INJECTION	AP	2010-11-29	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A090315-001	MIDAZOLAM HYDROCHLORIDE PRESERVATIVE FREE	EQ 1MG BASE/ML	INJECTABLE / INJECTION	AP	2010-11-29	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A090315-002	MIDAZOLAM HYDROCHLORIDE PRESERVATIVE FREE	EQ 5MG BASE/ML	INJECTABLE / INJECTION	AP	2010-11-29	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A090315-001	MIDAZOLAM HYDROCHLORIDE PRESERVATIVE FREE	EQ 1MG BASE/ML	INJECTABLE / INJECTION	AP	2010-11-29	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A090315-002	MIDAZOLAM HYDROCHLORIDE PRESERVATIVE FREE	EQ 5MG BASE/ML	INJECTABLE / INJECTION	AP	2010-11-29	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A090315-001	MIDAZOLAM HYDROCHLORIDE PRESERVATIVE FREE	EQ 1MG BASE/ML	INJECTABLE / INJECTION	AP	2010-11-29	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A090315-002	MIDAZOLAM HYDROCHLORIDE PRESERVATIVE FREE	EQ 5MG BASE/ML	INJECTABLE / INJECTION	AP	2010-11-29	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A090315-001	MIDAZOLAM HYDROCHLORIDE PRESERVATIVE FREE	EQ 1MG BASE/ML	INJECTABLE / INJECTION	AP	2010-11-29	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A090315-002	MIDAZOLAM HYDROCHLORIDE PRESERVATIVE FREE	EQ 5MG BASE/ML	INJECTABLE / INJECTION	AP	2010-11-29	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A090315-001	MIDAZOLAM HYDROCHLORIDE PRESERVATIVE FREE	EQ 1MG BASE/ML	INJECTABLE / INJECTION	AP	2010-11-29	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A090315-002	MIDAZOLAM HYDROCHLORIDE PRESERVATIVE FREE	EQ 5MG BASE/ML	INJECTABLE / INJECTION	AP	2010-11-29	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A090315-001	MIDAZOLAM HYDROCHLORIDE PRESERVATIVE FREE	EQ 1MG BASE/ML	INJECTABLE / INJECTION	AP	2010-11-29	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A090315-002	MIDAZOLAM HYDROCHLORIDE PRESERVATIVE FREE	EQ 5MG BASE/ML	INJECTABLE / INJECTION	AP	2010-11-29	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A090315-001	MIDAZOLAM HYDROCHLORIDE PRESERVATIVE FREE	EQ 1MG BASE/ML	INJECTABLE / INJECTION	AP	2010-11-29	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A090315-002	MIDAZOLAM HYDROCHLORIDE PRESERVATIVE FREE	EQ 5MG BASE/ML	INJECTABLE / INJECTION	AP	2010-11-29	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A090315-001	MIDAZOLAM HYDROCHLORIDE PRESERVATIVE FREE	EQ 1MG BASE/ML	INJECTABLE / INJECTION	AP	2010-11-29	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A090315-002	MIDAZOLAM HYDROCHLORIDE PRESERVATIVE FREE	EQ 5MG BASE/ML	INJECTABLE / INJECTION	AP	2010-11-29	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A090315-001	MIDAZOLAM HYDROCHLORIDE PRESERVATIVE FREE	EQ 1MG BASE/ML	INJECTABLE / INJECTION	AP	2010-11-29	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A090315-002	MIDAZOLAM HYDROCHLORIDE PRESERVATIVE FREE	EQ 5MG BASE/ML	INJECTABLE / INJECTION	AP	2010-11-29	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A090315-001	MIDAZOLAM HYDROCHLORIDE PRESERVATIVE FREE	EQ 1MG BASE/ML	INJECTABLE / INJECTION	AP	2010-11-29	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A090315-002	MIDAZOLAM HYDROCHLORIDE PRESERVATIVE FREE	EQ 5MG BASE/ML	INJECTABLE / INJECTION	AP	2010-11-29	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A090315-001	MIDAZOLAM HYDROCHLORIDE PRESERVATIVE FREE	EQ 1MG BASE/ML	INJECTABLE / INJECTION	AP	2010-11-29	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A090315-002	MIDAZOLAM HYDROCHLORIDE PRESERVATIVE FREE	EQ 5MG BASE/ML	INJECTABLE / INJECTION	AP	2010-11-29	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A090315-001	MIDAZOLAM HYDROCHLORIDE PRESERVATIVE FREE	EQ 1MG BASE/ML	INJECTABLE / INJECTION	AP	2010-11-29	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A090315-002	MIDAZOLAM HYDROCHLORIDE PRESERVATIVE FREE	EQ 5MG BASE/ML	INJECTABLE / INJECTION	AP	2010-11-29	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A090315-001	MIDAZOLAM HYDROCHLORIDE PRESERVATIVE FREE	EQ 1MG BASE/ML	INJECTABLE / INJECTION	AP	2010-11-29	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A090315-002	MIDAZOLAM HYDROCHLORIDE PRESERVATIVE FREE	EQ 5MG BASE/ML	INJECTABLE / INJECTION	AP	2010-11-29	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A090315-001	MIDAZOLAM HYDROCHLORIDE PRESERVATIVE FREE	EQ 1MG BASE/ML	INJECTABLE / INJECTION	AP	2010-11-29	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A090315-002	MIDAZOLAM HYDROCHLORIDE PRESERVATIVE FREE	EQ 5MG BASE/ML	INJECTABLE / INJECTION	AP	2010-11-29	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A090315-001	MIDAZOLAM HYDROCHLORIDE PRESERVATIVE FREE	EQ 1MG BASE/ML	INJECTABLE / INJECTION		2010-11-29	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A090315-002	MIDAZOLAM HYDROCHLORIDE PRESERVATIVE FREE	EQ 5MG BASE/ML	INJECTABLE / INJECTION		2010-11-29	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A090315-001	MIDAZOLAM HYDROCHLORIDE PRESERVATIVE FREE	EQ 1MG BASE/ML	INJECTABLE / INJECTION		2010-11-29	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A090315-002	MIDAZOLAM HYDROCHLORIDE PRESERVATIVE FREE	EQ 5MG BASE/ML	INJECTABLE / INJECTION		2010-11-29	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A090315-001	MIDAZOLAM HYDROCHLORIDE PRESERVATIVE FREE	EQ 1MG BASE/ML	INJECTABLE / INJECTION		2010-11-29	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A090315-002	MIDAZOLAM HYDROCHLORIDE PRESERVATIVE FREE	EQ 5MG BASE/ML	INJECTABLE / INJECTION		2010-11-29	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A090315-001	MIDAZOLAM HYDROCHLORIDE PRESERVATIVE FREE	EQ 1MG BASE/ML	INJECTABLE / INJECTION	AP	2010-11-29	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A090315-002	MIDAZOLAM HYDROCHLORIDE PRESERVATIVE FREE	EQ 5MG BASE/ML	INJECTABLE / INJECTION	AP	2010-11-29	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A090315-001	MIDAZOLAM HYDROCHLORIDE PRESERVATIVE FREE	EQ 1MG BASE/ML	INJECTABLE / INJECTION		2010-11-29	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	A090315-002	MIDAZOLAM HYDROCHLORIDE PRESERVATIVE FREE	EQ 5MG BASE/ML	INJECTABLE / INJECTION		2010-11-29	`bb7c543d1eb4…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 2 · 44 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-08-18 06:07:40	2026-07	A090315-001	AP	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A090315-002	AP	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A090315-001	AP	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A090315-002	AP	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A090315-001	AP	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A090315-002	AP	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A090315-001	AP	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A090315-002	AP	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A090315-001	AP	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A090315-002	AP	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A090315-001	AP	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A090315-002	AP	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A090315-001	AP	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A090315-002	AP	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A090315-001	AP	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A090315-002	AP	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A090315-001	AP	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A090315-002	AP	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A090315-001	AP	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A090315-002	AP	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A090315-001	AP	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A090315-002	AP	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A090315-001	AP	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A090315-002	AP	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A090315-001	AP	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A090315-002	AP	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A090315-001	AP	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A090315-002	AP	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A090315-001	AP	1	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A090315-002	AP	1	`8072bd15b7f6…`
2019-12-13 00:20 UTC	2019-12	A090315-001	AP	1	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A090315-002	AP	1	`74a2ff9319b5…`
2019-12-14 00:12 UTC	2019-12	A090315-001	AP	1	`3f01610625f2…`
2019-12-14 00:12 UTC	2019-12	A090315-002	AP	1	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A090315-001	AP	1	`b00525d2431f…`
2019-09-15 20:21 UTC	2019-09	A090315-002	AP	1	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A090315-001	AP	1	`ea99ee380514…`
2019-07-19 19:46 UTC	2019-07	A090315-002	AP	1	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A090315-001	AP	1	`6a51e52b5d6a…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A090315-002	AP	1	`6a51e52b5d6a…`

Additional Listing Data#

Finished product: Yes
Brand name base: Midazolam
Listing expiration: 2026-12-31

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
MIDAZOLAM HYDROCHLORIDE	2 mg/2mL

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
W7TTW573JJ	Internal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
1666798	Internal RxNorm lookup

Harmonized SPL set identifiers#

SPL set identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
d9305142-417d-4d8c-9a23-f9a1b6771cac	Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product concept	Relation	Version	Effective
1d526338-43ba-4cef-8730-5a757122f8ce	Product name	1	20260218
8118475d-d61b-4326-b353-56e9cf8c8d9f	Product name	3	20260218
f69f3735-bf62-03e6-cc7a-5af4af89ec8a	Product name	5	20250516
4cc03496-da49-494d-b71d-757fe6737fa2	Product name	1	20230717
06641162-4d53-492d-8ff2-5951a469060f	Product name	1	20230420
46ca420c-e4d5-4e6c-9b2f-cea269a262e8	Product name	1	20230320
b84efe2b-3f4e-4b09-90f9-1d24a61ec30e	Product name	1	20190808
bb7f99f4-8b2b-42a4-8f5a-fcf7dc204f16	Product name	1	20181220
31f18c4e-1938-700a-43de-b9e218c36edc	Product name	1	20140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
70518-4328-0	Midazolam	10 in 1 CARTON	INJECTION, SOLUTION	10		2
70518-4328-1	Midazolam	2 mL in 1 VIAL	INJECTION, SOLUTION	2		2

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
70518-4328	MIDAZOLAM (MIDAZOLAM HYDROCHLORIDE) INJECTION, SOLUTION [REMEDYREPACK INC.]	1	Current NDC, 2 package rows	20250418_d9305142-417d-4d8c-9a23-f9a1b6771cac.zip

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 1 · 3 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Midazolam	MIDAZOLAM HYDROCHLORIDE	Onesource Specialty Pharma Limited	54ed43b2-bad1-4b45-e063-6294a90a793a	2026-06-23	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 090315 application number: ANDA090315
Midazolam	MIDAZOLAM HYDROCHLORIDE	REMEDYREPACK INC.	d9305142-417d-4d8c-9a23-f9a1b6771cac	2025-10-02	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 090315 application number: ANDA090315 ndc (product): 70518-4328
Midazolam	MIDAZOLAM HYDROCHLORIDE	SOMERSET THERAPEUTICS, LLC	74666098-1ca8-4c06-8fc4-5de870b1b514	2023-12-05	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 090315 application number: ANDA090315

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
W7TTW573JJ	MIDAZOLAM HYDROCHLORIDE	59467-96-8	MIDAZOLAM HYDROCHLORIDE

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	DailyMed	SPL version
1666798	midazolam 2 MG in 2 ML Injection	PSN	d9305142-417d-4d8c-9a23-f9a1b6771cac	2
1666798	2 ML midazolam 1 MG/ML Injection	SCD	d9305142-417d-4d8c-9a23-f9a1b6771cac	2
1666798	midazolam 2 MG per 2 ML Injection	SY	d9305142-417d-4d8c-9a23-f9a1b6771cac	2

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Sample	Exclude flag	Status
70518-4328-0	70518432800	10 VIAL in 1 CARTON (70518-4328-0) / 2 mL in 1 VIAL (70518-4328-1)	10 vial	2025-04-14	No	No	Current
70518-4328-1	70518432801	2 mL in 1 VIAL	2 ml				Historical

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Midazolam Injection, USP For intravenous or intramuscular use	REMEDYREPACK INC.	2025-10-02	HUMAN PRESCRIPTION DRUG LABEL	2